Clinical Research Coordinator
Novavax - Maryland

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Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.

We are seeking a Clinical Research Coordinator (CRC) to work in our Rockville, MD Clinical Development Department. The Clinical Research Coordinator (CRC) will provide support to the Clinical Project Manager in the execution of one or more phase 1-4 clinical trials from protocol through clinical study report finalization for regulatory submission. Ensure compliance with ICH-GCP, FDA/ EMA, other regulations and SOPs, as applicable. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Responsible for the management of CROs and ensure adherence to scope of work within timelines and budget.

Responsibilities include but are not limited to:
Collect, process and track regulatory documentation as required by the Food and Drug Administration and other national regulatory authorities.
Provide general administrative support, including travel arrangements; scheduling and coordination of meetings; material and document shipments; coordination of correspondence, copying, filing, etc.
Serve as liaison with purchasing/shipping department to ensure adequate supplies are ordered.
Coordinate, process and track shipments to clinical sites in a timely fashion;
Coordinate shipping of investigational materials with Clinical Trial Manager (CTM), CRA, Operations, and QA/QC.
Ensure that clinical sites receive all supplies necessary for study conduct;
Create and maintain clinical study files.
Prepare Regulatory Binders and Operations Manuals for clinical sites, and ensure that sites receive all updates to both.
Revise study documents as requested.
Circulate documents (i.e., contracts, clinical study reports, protocols, etc.) for review and approval.
Draft meeting agendas and minutes as needed.
Draft confidentiality agreements and circulate for execution.
Adhere to standard operating procedures (SOPs).
Assist with budget and timeline tracking and updating.
Support CTM and CRA with study-specific tasks as needed, and provides weekly updates to team.
Coordinate and execute other assigned project tasks to meet departmental and corporate goals.
Other additional duties, as requested.

Minimum Requirements:
BS/BA degree or equivalent (background in life sciences preferred)
Detail oriented with strong organizational skills
Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project
Ability to travel globally up to 30% of time

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax - 11 months ago - save job - block
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